The Food and Drug Administration and the Centers for Disease Control and Prevention are calling for an immediate halt on the single-dose Johnson & Johnson coronavirus vaccine after six recipients in the United States developed a rare blood clotting disorder within two weeks of vaccination.
On Tuesday, the FDA and the CDC issued a joint statement recommending a pause on the use of the vaccine "out of an abundance of caution," adding that the "adverse events" in the six recipients appear to be "extremely rare."
According to The New York Times, the reported cases were all women between the ages of 18 and 48. One woman died and a second woman has been hospitalized in critical condition.
"CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases," the statement read.
"Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot," the agencies added.
The FDA and CDC also noted that "treatment of this specific type of blood clot is different from the treatment that might typically be administered."
More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the United States, according to CDC data.
A news conference regarding the recommendation is scheduled for 10 a.m ET Tuesday, the FDA announced.
Following the announcement by the FDA and CDC, Johnson & Johnson issued a statement confirming that the company is "aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines," ABC News reported.
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"At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine," the statement read. "We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public."
"The safety and well-being of the people who use our products is our number one priority. We share all adverse event reports about individuals receiving our COVID-19 vaccine, along with our assessment of these reports, with health authorities in compliance with regulatory standards," Johnson & Johnson said.
As of Tuesday morning, there have been more than 31.2 million reported cases of the coronavirus in the U.S. and at least 562,007 deaths, according to data from the Times.
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